Click to edit Master title style Investor Presentation July 10, 2017 nuvopharmaceuticals.com TSX: NRI Nuvo Pharmaceuticals™ Inc. Click Harbour Safe to edit Master title style Certain information to be discussed during this corporate update contains forward-looking statements within the meaning of applicable securities laws including, among others, statements concerning the Company’s 2017 objectives, the Company’s strategies to achieve those objectives, as well as statements with respect to Management’s beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Such forward-looking statements reflect Management’s current beliefs as of the date hereof and are based on information currently available to Management. These statements are not guarantees of future performance and are based on the Company’s estimates and assumptions and are subject to risks and uncertainties, including those described in the Company’s Management Discussion and Analysis regarding the 2016 annual audited financial statements and news releases, which could cause the Company’s actual results to differ materially from the forward-looking statements to be discussed during this presentation. Although the forward-looking information discussed during this presentation is based upon what Management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or 2 otherwise. nuvopharmaceuticals.com | TSX: NRI Click to edit Non-IFRS Measures Master title style EBITDA is a non-IFRS financial measure. The term EBITDA does not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies. The Company defines Adjusted EBITDA as net income from continuing operations before net interest income, plus taxes, depreciation, amortization and stock based compensation. Management believes Adjusted EBITDA is a useful supplemental measure from which to determine the Company’s ability to generate cash available for working capital, capital expenditures and income taxes. 3 nuvopharmaceuticals.com | TSX: NRI Click to edit Master title style Nuvo Pharmaceuticals 4 Nuvo Pharmaceuticals Click to edit Master title style Highlights • Commercial stage healthcare company • 3 commercial products: Pennsaid 2%, Pennsaid, HLT Patch • Cash flow positive and profitable • 2016 revenue grew 32% over 2015 • Strong barriers to entry: long-life IP and long-term contracts • FDA licensed manufacturing facility located in Québec • Future revenue growth • Pennsaid 2% out-licensing in international markets • M&A plan to acquire accretive products and businesses • Strong balance sheet with $18.6 million of cash and short-term investments and no debt (March 31, 2017) 5 nuvopharmaceuticals.com | TSX: NRI Our Lead Product: Pennsaid 2% Click to edit Master title style FDA Approved and Selling in the U.S. Topical and Transdermal Drug Delivery Market Indication Benefits U.S. Commercial Status • • 27M U.S. patients with osteoarthritis Targeting U.S. NSAID market • Treating the pain of osteoarthritis of the knee • • • Low systemic exposure to minimize side effects Only twice per day dosed topical NSAID in U.S. Metered dose dispenser • U.S. rights sold to Horizon Pharma in October 2014 for US$45 million Nuvo is Horizon’s exclusive long-term manufacturer to 2029 • • Follow-on product to Pennsaid, contains 2% diclofenac sodium Intellectual Property nuvopharmaceuticals.com | TSX: NRI • • Multiple patents listed in the FDA Orange Book continuing to 2030 4 generics have settled with Horizon for a 2029 entry date Recent court decision blocks Actavis (first generic filer) 6 until at least 2027 Commercial Partners Sell Our Approved Click to edit Master title style Products Pennsaid / Pennsaid 2% HLT Patch 7 nuvopharmaceuticals.com | TSX: NRI Pennsaid 2% U.S. Average Total Bottles Click to edit Master title style Dispensed Weekly Per Period Average Total Bottles/Week 11,000 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Horizon launch January 1, 2015 Source: IMS Health nuvopharmaceuticals.com | TSX: NRI Pennsaid 2% U.S. Average Total Bottles Click to edit Master title style Dispensed Weekly Per Month Average Total Bottles/Week 11,000 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Horizon launch January 1, 2015 Source: IMS Health nuvopharmaceuticals.com | TSX: NRI Click to edit Pennsaid 2%Master U.S. Growth title style Opportunity • Sold in U.S. by Horizon Pharma (NASDAQ:HZNP), a US$1.7 billion market cap U.S. biopharmaceutical company utilizing its Primary Care and Rheumatology sales force • Horizon’s top-selling Primary Care product • Pennsaid 2% is the only 2X per day topical NSAID available in the U.S. • Only topical NSAID competitor in the U.S. is Voltaren Gel • • • • Requires 4X per day dosing Went generic in 2016 No sales force promoting it Total sales of branded and generic versions have plateaued 10 nuvopharmaceuticals.com | TSX: NRI Click to edit Product Sales Master to Nuvo title Partners/Gross style Margin CDN$ Thousands Gross Margin on Gross Margin on Gross Margin on Product Sales Product Sales Product Sales Q1 - 57% Q2 - 57% Q4 - 57% 8,000 7,000 6,000 5,000 4,000 3,000 Gross Margin on Product Sales Q1 - 58% Gross Margin on Gross Margin on Product Sales Q4 - 51% Product Sales Q3 - 49% Gross Margin on Product Sales Q3 - 50% Gross Margin on Product Sales Q1 - 35% Gross Margin on Product Sales Q2 - 35% 2,000 1,000 0 Pennsaid 2% Pennsaid HLT Bulk 11 Click to 2016 Performance edit Mastervs title 2015 style (January 1 to December 31) CDN$ Millions 30 $27.0 26 22 $20.5 18 $13.5 14 $8.8 10 $8.0 $8.9 6 2 Total Revenue -2 Gross Margin 2015 (1) Adjusted EBITDA is a non- GAAP measure defined on slide 3 nuvopharmaceuticals.com | TSX: NRI Adjusted EBITDA(1) 2016 12 Click Q1 2017 to edit Performance Master title style CDN$ Millions 10 8 $7.0 6 $3.9 4 $2.3 2 0 Total Revenue Gross Margin Adjusted EBITDA(1) Q1 2017 (1) Adjusted EBITDA is a non- GAAP measure defined on slide 3 nuvopharmaceuticals.com | TSX: NRI 13 ClickSerialization U.S. to edit Master Legislation title styleChanges • On November 27, 2017, all U.S. pharmaceutical products must be individually serialized • Nuvo has shut down commercial bottle production to install new equipment that can individually serialize each commercial bottle • Nuvo expects to start manufacturing individually serialized product with newly installed equipment in Q3 2017 • Horizon plans to draw down its non-serialized inventory in Q2 and Q3 ahead of November 27th serialization implementation date • Nuvo anticipates a weak Q2 and Q3 as a result • Nuvo expects Horizon to rebuild inventory with serialized product purchased from Nuvo 14 nuvopharmaceuticals.com | TSX: NRI Nuvo Pharmaceuticals Strategy to Increase Click to edit Master title style and Diversify Revenue Streams • Most of Nuvo’s revenue is being generated by Pennsaid 2% in the U.S. • Create a global Pennsaid 2% franchise by out-licensing to strong commercial partners throughout the world • Acquire complementary strategic assets through M&A to increase sales and profitability 15 nuvopharmaceuticals.com | TSX: NRI Pennsaid 2% Click to edit Master title style International Out-Licensing Opportunities Indication | Acute pain for sprains and strains Available for out-licensing Licensed, not yet launched Launched 2014 Status | E.U., Canada and Australia may require additional clinical trial for approval Most other jurisdictions will base approval on existing U.S. FDA approval nuvopharmaceuticals.com | TSX: NRI 16 $1.5B Global Topicaltitle Diclofenac Market Click to edit Master style (USD in 2015) Middle East North Africa, $51,000,000 Asia (incl. Australia), $130,000,000 South America, $100,000,000 Europe, $550,000,000 North America, $635,000,000 17 nuvopharmaceuticals.com | TSX: NRI Click toLicensing Target edit Master Agreement title styleStructure • Modest upfront payments on signing/regulatory approval • Royalties based on net sales in the territory and/or transfer pricing • Exclusive long-term manufacturing agreement • Licensee responsibility for obtaining and maintaining regulatory approval utilizing drug dossier provided by Nuvo 18 nuvopharmaceuticals.com | TSX: NRI Click to Nuvo M&A editFocus Master title style GLOBAL Drugs/Companies OTC/Rx/select Devices Brands or select Generics Intellectual Property and/or Barriers to Entry (Manufacturing etc.) Initial Acquisition Criteria for Nuvo Utilize Varennes semisolids/liquids manufacturing capacity and expertise Opportunity to create value Currently generating Cash Flow or well defined path to commercialization 19 nuvopharmaceuticals.com | TSX: NRI Click to edit Master title style Manufacturing 20 Click to edit Master title style Manufacturing • Facility in Varennes Québec is FDA, Health Canada and MHRA approved • Manufactures Pennsaid, Pennsaid 2% and HLT Patch bulk for the global market • 26,000 square foot facility with 3 production lines, 2 compounding rooms • Specialized expertise in semi-solids and non-sterile liquids • Fully integrated pharmaceutical manufacturer with in-house capabilities including: • Quality Assurance • Quality Control (Including a Microbiology Laboratory) • Logistics & Purchasing • Experienced management team with an average of 20 years of pharmaceutical manufacturing industry experience • Capacity utilization of commercial bottles is approximately 35%* 21 nuvopharmaceuticals.com | TSX: NRI *have ability to add a second shift when required Click to edit Master title style Manufacturing Manufacturing Lines ● Compounding ● Unit Dose Manufacturing nuvopharmaceuticals.com | TSX: NRI 22 Click to edit Upcoming Pennsaid Master title 2% style Potential Milestones Q3 – Q4 2017 International licensing transactions completed and announced Q3 – Q4 2017 Product acquisitions(s) completed and announced 2018/2019 Regulatory approvals obtained and revenues commence from international licensing and product acquisition transactions 23 nuvopharmaceuticals.com | TSX: NRI Click to edit Financial Snapshot Master title style Stock Symbol TSX: NRI Market Cap (July 10/17) $48.5 million at $4.20 per share Shares Outstanding 11.6 million 52 Week Share Price Low-High $3.95 - $8.35 Cash & Short-Term Investments $18.6 million Debt NIL Revenue $20.5 million (2015) $27.0 million (2016) Headquarters Mississauga, ON (March 31/17) 24 nuvopharmaceuticals.com | TSX: NRI Click to edit Master Management Team title style John London • Over 30 years management experience and over 12 years of pharmaceutical experience • Formerly Co-CEO of Nuvo Research since 2009, previously Nuvo’s Vice-Chairman since 2005 • Graduate of the University of Western Ontario law school and holds a Masters of Law Degree from University College London Jesse Ledger • Over 15 years of pharmaceutical business development • Prior to joining Nuvo in April 2016, was Vice President, Business Development & International Business of Tribute Pharmaceuticals Canada • Holds an honours Bachelor of Business Administration degree from Trent University Mary-Jane Burkett • Over 4 years of pharmaceutical experience • Chartered Professional Accountant and holds an honours Bachelor of Business Administration degree from the Ivey Business School, University of Western Ontario Tina Loucaides • Over 14 years of legal experience in the biotechnology and pharmaceuticals area • Nuvo’s General Counsel since 2008 • Graduate of Osgoode Hall Law School and holds a Bachelor degree and a Master of Science degree from the University of Toronto Cally Lunetta • Over 30 years of pharmaceutical manufacturing experience • 15 years overseeing the Nuvo manufacturing facility • Holds a Bachelor of Science degree from McGill University Chief Executive Officer President Vice President & CFO Vice President, Secretary & General Counsel Vice President, Manufacturing 25 nuvopharmaceuticals.com | TSX: NRI Click toofedit Board Directors Master title style Dan Chicoine Chairman (Executive Chairman & Interim CEO, Crescita Therapeutics Inc.) • Formerly Co-CEO of Nuvo Research since 2009, and Nuvo’s Chairman since 2005 • BComm from the University of Toronto and is also a Chartered Professional Accountant Jacques Messier Chair of the Governance, Compensation & Nominating Committee (Chief Executive Officer, Toronto Humane Society) • DVM from the University of Montreal and an MBA from the University of Western Ontario David Copeland Robert Harris (Former CFO of Magna International Inc. and CEO of the Cosma Group of Magna) • BMath from the University of Waterloo and is also a Chartered Professional Accountant (Director, Aralez Pharmaceuticals Inc. and CannaRoyalty Corp.) • Former co-founder, President & CEO of Tribute Pharmaceuticals Anthony Dobranowski John London (Former Vice President of Magna, and prior to that held various executive positions (Vice Chairman, President and CFO) at Tesma International Inc., a public subsidiary of Magna) • Formerly Co-CEO of Nuvo Research since 2009, previously Nuvo’s Vice-Chairman since 2005 • Graduate of the University of Western Ontario law school and holds a Masters of Law Degree from University College London Lead Director Director Director Director and CEO • MBA from the University of Toronto and is also a Chartered Professional Accountant 26 nuvopharmaceuticals.com | TSX: NRI Nuvo Pharmaceuticals Click to edit Master title style Highlights • Commercial stage healthcare company • 3 commercial products: Pennsaid 2%, Pennsaid, HLT Patch • Cash flow positive and profitable • 2016 revenue grew 32% over 2015 • Strong barriers to entry: long-life IP and long-term contracts • FDA licensed manufacturing facility located in Québec • Future revenue growth • Pennsaid 2% out-licensing in international markets • M&A plan to acquire accretive products and businesses • Strong balance sheet with $18.6 million of cash and short-term investments and no debt (March 31, 2017) 27 nuvopharmaceuticals.com | TSX: NRI Click to edit Master title style To discuss opportunities contact: Investor Relations (905) 673-3627 [email protected] nuvopharmaceuticals.com
© Copyright 2025 Paperzz